Cross-DisciplinaryWorking Groups

Analytical Leadership Group

The IQ Analytical Leadership Group’s mission is to advance science-based standards and regulations for both small and large molecule medicinal products by proactively addressing scientific and regulatory issues related to global registration of analytical procedures and their validation, specifications, other relevant CMC documentation and compendial standards, and quality control testing of clinical and commercial products.

The ALG is either overseeing or participating in a variety of Working Groups, several of which are collaborations with other IQ Leadership Groups. These include the Analytical QbD, API Starting Materials, Biologics, Characterization of Amorphous Dispersions, Dissolution, Impurity Control, Industry Framework for Developing Co-Crystals, Process Analytical Technology, Small Molecule Components of Biologics Working Groups. The ALG has completed the work in its Analytical Methods Comparability and GMPs in Early Development Working Groups, and these two working groups can be found in the “archived Working Groups” page.